Components of a fluid transfer apparatus

ABSTRACT

A syringe that is configured for use in a syringe pump. The syringe has a flange at the proximal end of a barrel and a sealing element at its proximal end. The sealing element has of a disk shaped annular sealing assembly having a hole in its center through which a piston rod passes. The sealing assembly has an upper part and a lower part that are pressed together to hold an O-ring that seals around the piston rod. The sealing assembly is placed inside the barrel of the syringe; thereby not disturbing the external shape of the syringe and allowing the syringe to fit into dedicated grooves on syringe pumps.

FIELD OF THE INVENTION

The present invention relates to the field of fluid transferapparatuses. Particularly, the invention relates to apparatus for thecontamination-free transfer of a hazardous drug from one container toanother or to a patient. More particularly, the invention relates toimprovements to syringes and to connectors and adapters that are used influid transfer apparatuses.

BACKGROUND OF THE INVENTION

Advances in medical treatment and improved procedures constantlyincrease the need for improved valves and connectors. The demandsrelating to a variety of types, quality, needle safety, microbialingress prevention and leak prevention are constantly growing.Additionally, advances in sampling or dose dispensing technologies,automated and manual, aseptic or non-aseptic applications, call for newsafe concealing solutions for the sampling needle. One extremelydemanding application exists in the field where medical andpharmacological personnel that are involved in the preparation andadministration of hazardous drugs suffer the risk of being exposed todrugs and to their vapors, which may escape to the surroundings. Asreferred to herein, a “hazardous drug” is any injectable material thecontact with which, or with the vapors of which, may constitute a healthhazard. Illustrative and non-limitative examples of such drugs include,inter aka, cytotoxins, antiviral drugs, chemotherapy drugs, antibiotics,and radiopharmaceuticals, such as herceptin, cisplatinum, fluorouracil,leucovorin, paclitaxel, etoposide, cyclophosphamide and neosar, or acombination thereof, in a liquid, solid, or gaseous state.

Hazardous drugs in liquid or powder form are contained within vials, andare typically prepared in a separate room by pharmacists provided withprotective clothing, a mouth mask, and a laminar flow safety cabinet. Asyringe provided with a cannula, i.e. a hollow needle, is used fortransferring the drug from a vial. After being prepared, the hazardousdrug is added to a solution contained in a bag which is intended forparenteral administration, such as a saline solution intended forintravenous administration.

Since hazardous drugs are toxic, direct bodily contact thereto, orexposure to even micro-quantities of the drug vapors, considerablyincreases the risk of developing health problems that can result infatalities such as skin cancer, leukemia, liver damage, malformation,miscarriage and premature birth. Such exposure can take place when adrug containing receptacle, such as a vial, bottle, syringe, andintravenous bag, is subjected to overpressure, resulting in the leakageof fluid or air contaminated by the hazardous drug to the surroundings.Exposure to a hazardous drug also results from a drug solution remainingon a needle tip, on a vial or intravenous bag seal, or by the accidentalpuncturing of the skin by the needle tip. Additionally, through the sameroutes of exposure, microbial contaminants from the environment can betransferred into the drug and fluids; thus eliminating the sterilitywith possibly fatal consequences.

U.S. Pat. Nos. 8,196,614 and 8,267,127 to the inventor of the presentinvention describe closed system liquid transfer devices designed toprovide contamination-free transfer of hazardous drugs. FIG. 1 and FIGS.3a to 3b are schematic cross-sectional views of an apparatus 10 fortransferring hazardous drugs without contaminating the surroundings,according to one embodiment of the invention described in U.S. Pat. No.8,196,614. The main features of this apparatus that are relevant to thepresent invention will be described herein. Additional details can befound in the aforementioned patent.

The proximal section of apparatus 10 is a syringe 12, which is adaptedto draw or inject a desired volume of a hazardous drug from a fluidtransfer component, e.g. a vial 16 or an intravenous (IV) bag in whichit is contained and to subsequently transfer the drug to another fluidtransfer component. At the distal end of syringe 12 is connected aconnector section 14, which is in turn connected to vial 16 by means ofvial adapter 15.

Syringe 12 of apparatus 10 is comprised of a cylindrical body 18 havinga tubular throat 20 that has a considerably smaller diameter than body18, an annular rubber gasket or stopper assembly 22 fitted on theproximal end of cylindrical body 18, hollow piston rod 24 whichsealingly passes through stopper 22, and proximal piston rod cap 26 bywhich a user can push and pull piston rod 24 up and down through stopper22. A piston 28 made of an elastomeric material is securely attached tothe distal end of piston rod 24. Cylindrical body 18 is made of a rigidmaterial, e.g. plastic.

Piston 28, which sealingly engages the inner wall of, and isdisplaceable with respect to, cylindrical body 18 defines two chambersof variable volume: a distal liquid chamber 30 between the distal faceof piston 28 and connector section 14 and a proximal air chamber 32between the proximal face of piston 28 and stopper 22.

Connector section 14 is connected to the throat 20 of syringe 12 bymeans of a collar which proximally protrudes from the top of connectorsection 14 and surrounds throat 20. Note that embodiments of theapparatus do not necessarily have a throat 20. In these embodimentssyringe 12 and connector section 14 are formed together as a singleelement at the time of manufacture, or permanently attached together,e.g. by means of glue or welding, or formed with a coupling means, suchas threaded engagement or a Luer connector. The connector section 14comprises a double membrane seal actuator which is moveable in areciprocating manner from a normal, first configuration in which theneedles are concealed when the double membrane seal actuator is disposedin a first, distal position and a second position in which the needlesare exposed when the double membrane seal actuator is proximallydisplaced. Connector section 14 is adapted to be releasably coupled toanother fluid transfer component, which can be any fluid container witha standard connector such as a drug vial, intravenous bag, or anintravenous line to produce a “fluid transfer assembly”, through which afluid is transferred from one fluid transfer component to another.

Connector section 14 comprises a cylindrical, hollow outer body; adistal shoulder portion 19, which radially protrudes from the body andterminates at the distal end with an opening through which the proximalend of a fluid transfer component is inserted for coupling; a doublemembrane seal actuator 34, which is reciprocally displaceable within theinterior of the body; and one or more resilient arms 35 serving aslocking elements, which are connected at a proximal end thereof to anintermediate portion of a cylindrical actuator casing that containsdouble membrane seal actuator 34. Two hollow needles that function asair conduit 38 and liquid conduit 40 are fixedly retained in needleholder 36, which protrudes into the interior of connector section 14from a central portion of the top of connector section 14.

Conduits 38 and 40 distally extend from needle holder 36, piercing theupper membrane of actuator 34. The distal ends of conduits 38 and 40have sharp pointed ends and apertures through which air and liquid canpass into and out of the interiors of the conduits respectively asrequired during a fluid transfer operation. The proximal end of airconduit 38 extends within the interior of proximal air chamber 32 insyringe 12. In the embodiment shown in FIG. 1, air conduit 38 passesthrough piston 28 and extends inside of hollow piston rod 24. Airflowing through conduit 38 enters/exits the interior of piston rod 24and exits/enters to air chamber 32 through an aperture formed at thedistal end of piston rod 24 just above piston 28. The proximal end ofliquid conduit 40 terminates at the top of or slightly proximally fromthe top of needle holder 36, so that the liquid conduit will be in fluidcommunication with the distal liquid chamber 30 via the interior ofthroat 20 of syringe 12.

Double membrane seal actuator 34 comprises a cylindrical casing thatholds a proximal disc shaped membrane 34 a having a rectangularcross-section and a two level distal membrane 34 b having a T-shapedcross-section with disc shaped proximal portion and a disc shaped distalportion disposed radially inwards with respect to the proximal portion.The distal portion of the distal membrane 34 b protrudes distally fromactuator 34. Two or more equal length resilient elongated arms 35 areattached to the distal end of the casing of actuator 34. The armsterminate with distal enlarged elements. When actuator 34 is in a firstposition, the pointed ends of conduits 38 and 40 are retained betweenthe proximal and distal membranes, isolating the ends of conduits 38 and40 from the surroundings, thereby preventing contamination of theinterior of syringe 12 and leakage of a harmful drug contained withinits interior to the surroundings.

Vial adapter 15 is an intermediate connection that is used to connectconnector section 14 to a drug vial 16 or any other component having asuitably shaped and dimensioned port. Vial adapter 15 comprises a diskshaped central piece to which a plurality of circumferential segments,formed with a convex lip on the inner face thereof for facilitatingsecurement to a head portion of a vial 16, are attached at thecircumference of the disk and pointing distally away from it and alongitudinal extension projecting proximally from the other side of thedisk shaped central piece. Longitudinal extension fits into the openingat the distal end of connector section 14 to allow transfer of the drugas described herein below. The longitudinal extension terminatesproximally with a membrane enclosure having a diameter larger than thatof the extension. A central opening in the membrane enclosure retainsand makes accessible a membrane 15 a.

Two longitudinal channels, which are internally formed within thelongitudinal extension and that extend distally from the membrane in themembrane enclosure, are adapted to receive conduits 38 and 40,respectively. A mechanical guidance mechanism is provided to insure thatthe conduits 38 and 40 will always enter their designated channel withinthe longitudinal extension when connector section 14 is mated with vialadapter 15. The longitudinal extension terminates distally with a spikeelement 15 b which protrudes distally. The spike element is formed withopenings in communication with the internally formed channels,respectively and openings at its distal pointed end.

Vial 16 has an enlarged circular head portion attached to the main bodyof the vial with a neck portion. In the center of the head portion is aproximal seal 16 a, which is adapted to prevent the outward leakage of adrug contained therein. When the head portion of vial 16 is insertedinto the collar portion of vial adapter 15 and a distal force is appliedto vial adapter 15, the spike element 15 b of the connector section 14pierces the seal 16 a of vial 16, to allow the internal channels in theconnector section 14 to communicate with the interior of drug vial 16.When this occurs, the circumferential segments at the distal end of thecollar portion of the connector section are securely engaged with thehead portion of vial 16. After the seal of vial 16 is pierced it sealsaround the spike preventing the outward leakage of the drug from thevial. At the same time the tops of the internal channels in vial adapter15 are sealed by the membrane 15 a at the top of vial adapter 15,preventing air or drug from entering or exiting the interior of vial 16.

The procedure for assembling drug transfer apparatus 10 is carried outas shown in FIGS. 2a to 2d : Step 1—After the vial 16 and vial adapter15 have been joined together, with spike element 15 b penetratingproximal seal 16 a of the vial, the membrane enclosure 15 a of vialadapter 15 is positioned close to the distal opening of connectorsection 14, as shown in FIG. 2a . Step 2—A double membrane engagementprocedure is initiated by distally displacing the body of connectorsection 14 with an axial motion until the membrane enclosure andlongitudinal extension of vial adapter 15 enters the opening at thedistal end of the connector section 14, as shown in FIG. 2b . Step 3—thedistal membrane 34 b of actuator 34 is caused to contact and be pressedagainst the stationary membrane 15 a of vial adapter 15 by additionaldistal displacement of the body of the connector section 14. After themembranes are pressed tightly together the enlarged elements at the endsof the arms of the connector section 14 are squeezed into the morenarrow proximal section of connector section 14 thereby holding themembranes pressed together and engaged around the longitudinal extensionand under the membrane enclosure of vial adapter 15, as shown in FIG. 2c, thereby preventing disengagement of the double membrane seal actuator34 from vial adapter 15. Step 4—Additional distal displacement of thebody of connector section 14, as shown in FIG. 2d , causes actuator 34to move proximally relative to the body of the connector section 15until the tips of conduits 38 and 40 pierce the distal membrane ofactuator 34 and the membrane at the top of vial adapter 15 and are influid communication with the interior of vial 16. These four steps areperformed by one continuous axial motion as connector section 14 isdistally displaced relative to the vial adapter 15, and they will bereversed to separate connector section 14 from vial adapter 15 bypulling connector section 14 and vial adapter 15 apart. It is importantto emphasize that the procedure is described herein as comprising fourseparate steps, however this is for ease in describing the procedureonly. It is to be realized that in actual practice the secured doublemembrane engagement (and disengagement) procedure using the presentinvention is carried out using a single smooth axial movement.

After drug transfer assembly 10 shown in FIG. 1 is assembled asdescribed hereinabove with reference to FIGS. 2a to 2d , the piston rod24 can be moved to withdraw liquid from vial 16 or to inject liquid fromthe syringe into the vial. The transfer of liquid between the distalliquid chamber 30 in the syringe 12 and liquid 48 in the vial 16 andtransfer of air between the proximal air chamber 32 in the syringe 12and air 46 in the vial 16 takes place by an internal pressureequalization process in which the same volumes of air and liquid areexchanged by moving through separate channels symbolically shown in FIG.1 by paths 42 and 44 respectively. This is a closed system whicheliminates the possibility of exchange of air or liquid drops or vaporbetween the interior of assembly 10 and the surroundings.

FIG. 3a schematically shows injection of a liquid into a vial. To injectliquid contained in the liquid chamber 30 of syringe 12 into the vial 16the drug transfer assembly 10 must be held vertically with the vial atthe bottom in an upright position as shown in FIG. 3a . Pushing piston28 distally pushes the liquid out of liquid chamber 30 through conduit40 into vial 16. Simultaneously, as the volume of liquid chamber 30 isreduced by the distally moving piston, the volume of air chamber 32 isincreased. This creates a temporary state of negative pressure in theair chamber and therefore air (or an inert gas) inside vial 16 will besucked through conduit 38 into air chamber 32. Additionally andsimultaneously, as the liquid is added to the vial, the volume availablefor the air in the vial is reduced creating a temporary state ofpositive pressure, therefore the air is forced from the vial 16 throughconduit 38 into air chamber 32, thus equalizing the pressures in thetransfer assembly 10 and equilibrium is reached when piston 28 stopsmoving.

FIG. 3b schematically shows withdrawal of liquid from a vial. Towithdraw liquid from the vial 16 and transfer it into the liquid chamber30 of syringe 12 the drug transfer assembly 10 must be inverted and heldvertically with the vial 16 in an upside-down position as shown FIG. 3b. For this operation, when apparatus 10 is assembled and the piston 28in syringe 12 is pulled in the proximal direction, a state of negativepressure is created in liquid chamber 30 and liquid is sucked into itthrough conduit 40. Simultaneously the volume of air chamber 32 isreduced and air is forced out of it through conduit 38 into the vial (inFIG. 3b are shown the air bubbles created by the air entering the vialfrom air chamber 40). As described in FIGS. 3a and 3b this simultaneoustransfer and replacing of equal volumes of gas and liquids respectivelyinside syringe and vial constitutes the closed system equalizationsystem.

Despite the care that was taken to separate air path 42 from liquid path44 there are two locations in the prior art assembly described in U.S.Pat. No. 8,196,614 in which these paths intersect under certainconditions allowing for the possibility of liquid to travel through theair conduit from the distal liquid chamber 30 or vial 16 to the proximalair chamber.

Specifically, in the prior art apparatus described in U.S. Pat. No.8,196,614 there is a direct connection between the air and liquidchannels:

-   -   A. inside the double membrane seal actuator 34, when the syringe        12 and attached connection section 14 are not connected to any        other fluid transfer component; and    -   B. inside the vial 16 at the tip of the spike, when the        apparatus 10 is assembled as shown in FIG. 1.

When part of the liquid does accidently find its way into the airchamber of the syringe, in addition to the obvious problems ofesthetics, additional time consuming working steps become necessary toretrieve the drug and correct the dosage.

An example of a scenario when situation A is relevant is when thesyringe contains liquid and is being handled, for example when beingtransported from the pharmacy to the ward. At such a time the piston rodmight be accidentally pushed causing some of the drug to migrate to theproximal air chamber above the piston from where it cannot be expelledfrom the syringe. In such case the plunger needs to be pulled back inorder to retrieve the drug, which is an extra work step and the wetresiduals in the air chamber 32 cause an aesthetic problem.

An example of a scenario when situation B is relevant is when, duringwithdrawal of a liquid drug from a vial which is in a typicalupside-down position, a bubble of air is seen to enter the liquidchamber of the syringe or when the syringe has been filled with morethan the desired volume of liquid. In these situations, accidentalpushing on the piston rod to return liquid or bubble to the vial willalso cause some liquid to be forced through the air channel into the airchamber in the syringe. The way to remove the bubble is a relativelytime consuming and complex procedure involving disconnecting the syringefrom the vial and reconnecting it. Special attention is required toavoid pushing the plunger accidentally, which slows down the speed ofwork.

PCT patent application WO2014/122643 to the inventor of the presentinvention describes improvements to the previously described drugtransfer devices that minimize or eliminate the above mentionedlimitations. Amongst the improvements taught in WO2014/122643 areembodiments of the drug transfer apparatus that comprises a hydrophobicfilter inserted in the air channel in at least one location between theair chamber in the syringe and the fluid transfer component and improvedvial adapters.

An inserted filter in the vial adapter serves as barrier between theliquid and air channels, thus preventing the transfer of liquid throughthe air channel to the air chamber formed at the back of the syringe.Due to insertion of such barrier the user is free to push small airbubbles or correct small over dosage back into the vial during awithdrawal procedure without being concerned that the drug might migrateto the air chamber. On the one hand working with a filter barrier seemsto be an advantage but on the other hand the user is motivated to somenegligence and it can be expected that users will not clear the filterfrom liquid before disconnecting the syringe from the vial and somepressure differentials might remain between the air and liquid chambersof the syringe. Therefore right after disconnection the pressuredifferentials will seek for neutralization and flow of fluids will occurfrom the chamber with the higher pressure to chamber with the lowerpressure until equilibrium is reached. In the case that the lowerpressure is in the air chamber, some of the liquid drug will be suckedfrom the liquid chamber to the air chamber through the path existingbetween both needle tips inside the double membrane seal actuator. Toavoid such migration or transfer due to accidental pushing or pullingthe plunger and generally to prevent any uncontrolled migration ofliquid to air the chamber, the existing path between the needle tipsmust be eliminated and total isolation of the needles is required.

Such isolation of the needles constitutes a design challenge. On the onehand, membrane 34 b serves as a barrier between the open ends of theneedles 38 and 40 and the environment, preventing contaminants such asmicroorganisms from contaminating the interior of actuator 34 and theneedle tips retained in it, thereby maintaining sterility. On the otherhand membrane 34 b also protects the environment from hazardoussubstances. While in the previous embodiment in FIG. 1 to FIG. 3b whereno filter barrier is used, there is no pressure differential createdbetween the air and liquid chambers, and therefore uncontrolledmigration doesn't occur, only accidental pushing or pulling can causetransfer of drug between chambers. Such accidental pushing, which (as aside note) is very common, does not create high pressure inside thedouble membrane seal actuator since there is free flow from chamber tochamber and high pressure cannot be maintained and collapses immediatelyuntil equilibrium is reached. Therefore the sealing properties of theelements in the actuator are never challenged with high pressure andmoderate design is sufficient. On the other hand, in embodimentsaccording to WO2014/122643 (see for example FIG. 4) where a filter 50 isinserted as a barrier, there is a requirement for high pressureresistance due to the high pressures of up to 20 atmospheres that can beeasily generated by manually pushing the syringe plunger. Thisphenomenon is especially common with small volume syringes (1-5 ml).Under such pressures most of the isolation designs between the needleswill fail and drug will be transferred to the air chamber or even worse,the membranes 34 a and 34 b cannot resist high pressures, which cancause them to detach from their seat or can cause a leak through thechannels in the membranes that were created by the needles duringpiercing the resilient material of the membrane.

PCT patent application WO2014/181320 and Israeli Patent Application No.234746, both to the inventor of the present invention, describe needlevalves that can be incorporated into the membrane actuator of theconnector section 14. The needle valves prevent the possibility ofliquid travel through the air conduit from the distal liquid chamber 30or vial 16 to the proximal air chamber when the connector section 14 isnot connected to a vial or other fluid transfer component. The needlevalves also simplify the construction of the membrane actuator making itpossible to use a single membrane actuator instead of a double membraneactuator as in the connector section shown in FIGS. 1-4.

FIG. 5a and FIG. 6a are schematic cross-sectional views of an apparatusfor transferring hazardous drugs. The apparatus and all of thecomponents shown in these figures are identical to those shown in FIG. 1and FIG. 2a respectively, with two exceptions. The vial adapter 15comprises a filter 50, as described in WO2014/122643 and the prior artdouble membrane seal actuator 34 in the connector section 14 comprisingtwo membranes 34 a and 34 b and arms 35 is replaced with an actuator 52comprising an embodiment of the needle valve 54, only one membrane 34 b,and arms 35. It is important to note that it is not necessary to sealthe proximal end of actuator 52 in any fashion because the task ofenclosing the ports 56 at the distal ends of the air and liquid conduitswhen the connector is not connected to another fluid transfer component,which in the prior art was accomplished by membranes 34 a and 34 b, isaccomplished in the single membrane actuator 52 by the needle valvearrangement and membrane 34 b alone and in some embodiments by theneedle valve itself.

FIG. 5a shows syringe 12 attached to connector section 14 and vialadapter 15 connected to drug vial 16. FIG. 6a shows all components ofthe apparatus connected together. FIG. 5b and FIG. 6b are enlarged viewsof the actuator in the apparatus shown in FIG. 5a and FIG. 6arespectively.

Referring to FIG. 5b and FIG. 6b , actuator 52 comprises a needle valve54 having a valve seat comprising two bores through which the needles ofair conduit 38 and liquid conduit 40 pass. It is noted that embodimentsof actuator 52 are also described that contain one bore for use inliquid transfer apparatus that comprises only one needle 38.

When the syringe and attached connector are not connected to any othercomponent of the apparatus, as shown in FIG. 5b , the actuator 52 is atthe distal end of connector section 14 and the tips of needles 38 and 40are located in the bores in the seat 54 of the needle valve. In thisconfiguration the ports 56 in the sides of the needles are blocked bythe interior walls of the bores completely isolating the needles fromeach other, thereby preventing air from entering the liquid chamber ofthe syringe or liquid from entering the air chamber.

When the syringe and attached connector are connected to anothercomponent of the apparatus, such as a vial adapter as shown in FIG. 6b ,the actuator 52 is pushed towards the proximal end of connector section14. Since needles 38 and 40 are fixed to the needle holder 36, asactuator 52 moves proximally, the tips of needles 38 and 40 and ports 56are pushed out through the distal end of the bores in the seat 54 of theneedle valve, through membrane 34 b, and through membrane 15 a of thevial adapter, thereby establishing open fluid paths in the respectivechannels.

The first goal for the connector is to completely eliminate thepossibility of migration of liquid to the air chamber. This can happen,for example, if pressure differentials between the air and liquidchambers exist after disconnection from a vial adapter and if thepressure in the air chamber is lower than that in the liquid chamber,resulting in undesired migration of liquid to the air chamber. Thesecond goal is to prevent leaks or damage to the connector duringaccidental pushing of the syringe plunger. One of the frequentlyperformed drug transfer operations in hospital settings is known as IVpush or bolus injection. Typically the required amount of drug isprepared in a syringe in the hospital pharmacy and delivered to the wardwhere a qualified nurse administers to the patient the drug through apreviously established IV line. A common problem associated with theprocedure is that during the trip from pharmacy to ward or at bedsidethe piston of the syringe is sometimes unintentionally pushed expellingsome of the drug from the barrel of the syringe or the piston isunintentionally pulled. High pressures of up to 20 atmospheres can beeasily generated by manually pushing the plunger of small volumesyringes (1-5 ml). Such pressure may cause the connector to disintegrateor the membranes to be detached. The connector shown in FIG. 5a throughFIG. 6b is proposed as a solution to the problems associated with suchunintended transfer of fluids between the air and liquid chambers and toresist high pressures created during accidental pushing the of plunger.As can be seen in these figures, when the connector 14 is not connectedto the adapter 15, the ports 56 at the distal end of needles 38 and 40that allow exchange of fluid between the surroundings and the hollowinteriors of the needles are blocked by the interior of the bore in seat54 of the needle valve. If the syringe is filled or partially filledwith liquid, then if a force is exerted to try to push the plungerforward and to force liquid to flow through the needle, no liquid canexit the needle through port 56. Conversely, if a force is exerted topull the plunger backwards no air can enter through port 56 and flowthrough the interior of the needle into the barrel of the syringe.

Israeli Patent Application No. 237788 to the inventor of the presentinvention describes embodiments of septum holders for use in syringeconnectors that are used to connect syringes to other elements of liquidtransfer apparatuses. All of the embodiments of the septum holdersdescribed in that patent application comprise a septum holder body, atleast one resilient elongated arm that terminates with a distal enlargedelement attached to the sides of the body, and a septum. The septumholders of IL237788 are characterized in that they comprise at least onebore that functions as the seat of a needle valve. The bore is createdin the septum or in an insert fixed in either the body of the septumholder or in the septum. The septum holders described in IL237788 arealso characterized in that the septum is attached to the bottom of thebody of the septum holder projecting downwards parallel to the at leastone elongated arm.

FIG. 7a , FIG. 7b , and FIG. 7c are respectively front, cross-sectional,and exploded views of an embodiment of a septum holder 58 described inIL237788. Septum holder 58 is comprised of a disk shaped annular body60. Two equal length resilient elongated arms 62 are attached to thesides of body 60. The arms terminate with distal enlarged elements 64.The bottom part of body 60 is comprised of a cylindrical section thatprojects downward between arms 62. A cavity 66 is created in the bottompart of body 60 into which is fitted an insert 68 comprising two bores70 that form the seat of a needle valve. In alternative embodimentsinsert 68 can have different shapes than that shown and in oneembodiment can be comprised of two separate pieces of tubing that areinserted into parallel bores of appropriate diameters created in thebottom part of body 60.

Septum 72 is made of a single piece of cylindrically shaped resilientmaterial. The upper part of septum 72 has a hollow interior forming acylindrical recess 74 having an inner diameter no larger than that ofthe outer diameter of the cylindrical section at the bottom of body 60.After insert 68 is fitted into cavity 66, septum 72 is pushed over thebottom part of body 60 until the solid part of septum 72 below recess 74butts against the bottom of bores 70 in insert 68 thereby isolating thebottoms of the interior of the bores from the external environment.Septum 72 is fixedly held on the body 60 of septum holder 58 by anymeans known in the art. For example, the resilient material of theseptum may be strong enough to grip the sides of the cylindrical sectionat the bottom of body 60 to hold the septum in place; or, as shown inFIG. 7c , the cylindrical section at the bottom of body 60 may havethreads or teeth 76, or an equivalent structure created on its outersurface and septum 72 may have similar structure on the inner diameterof its hollow interior (not shown in FIG. 7c ) so that the twostructures interlock when septum 72 is pushed over the bottom part ofbody 60. In other embodiments other methods, such as gluing, ultrasonicforming, or laser or ultrasound welding may be used. The lowest part ofseptum 72 has a diameter that matches that of the septum in the fluidtransfer component, e.g. vial adapter, to which it will be connected.

FIG. 7d schematically shows the holder of FIG. 7a , FIG. 7b , and FIG.7c in a syringe connector section of a closed system liquid transferapparatus. The connector section is essentially the same as that in theprior art apparatus described herein above. Cylindrical body 78 of theconnector section is attached to syringe 80. Two hollow needles—82,which function as an air conduit, and 84, which functions as a liquidconduit—are fixedly attached to the upper end of body 78 of theconnector section. At the lower end of the needles, adjacent to thepointed distal tips, are ports 86 that allow fluid communication betweenthe exterior and the hollow interiors of the needles. External ridges 88near the bottom of cylindrical body 78 serve as finger grips for usewhen attaching the connector section and syringe to other elements ofthe drug transfer system. Ridges 88 are not essential and can beeliminated or replaced with other means, for example a roughened surfacearea, to accomplish the same purpose.

A septum holder 58 is located inside of cylindrical body 78 of theconnector section. As shown, the distal ends of needles 82,84 areinserted into bores 70 in insert 68 (see FIG. 7c ). If the insert 68 ismade of a flexible material, e.g. silicon, the diameters of bores 70 aresmaller than the outer diameter of the shafts of the needles andtherefore the resilient material of which the insert is manufacturedpushes radially against the shaft of the needle sealing the ports 86.When not connected to another element of a liquid transfer system thedistal enlarged elements 64 of arms 62 are engaged in the shoulderportion 90 at the distal end of body 78. As shown in FIG. 7d , in thisposition the tips of the needles are isolated from the outside by septum72 at the bottom and the walls of the bores 70 pressing radially on theshafts of the needles prevent fluids from entering or exiting theinterior of the needles.

Connection of the syringe connector to a fluid transfer component, e.g.a vial adapter, a spike adapter for connection to an IV bag, or aconnector for connection to an IV line, is accomplished in the samemanner as in the prior art described herein above. When the septum ofthe fluid transfer component is pushed against septum 72, septum holder58 begins to move upwards inside body 78 and the tips of the needlesbegin to exit bores 70 and penetrate the solid material of septum 72.The tips of the needles pass through septum 72 and the septum of thefluid transfer component as holder 58 continues to be pushed upwards,thereby establishing air and liquid channels between the element of theliquid transfer system attached to the fluid transfer component and theproximal air chamber and distal liquid chamber in the syringe.

It is a purpose of the present invention to provide improved versions ofsome of the components of the fluid transfer apparatuses of the priorart that will result in simplified manufacturing processes, easier andmore efficient use of the components, and safer transfer of liquids.

Further purposes and advantages of this invention will appear as thedescription proceeds.

SUMMARY OF THE INVENTION

In a first aspect the invention is a septum holder comprising acylindrically shaped annular body, at least one resilient arm, and aseptum that is fixedly attached to the bottom of the body. Each of theat least one arms comprises a distal enlarged element having a roundedoutwardly facing rear side and a pointed inwardly facing front side andthe enlarged elements at the distal end of the arms move back and forthalong lines that are parallel to chords of the circular cross-section ofthe body of the septum holder.

Embodiments of the septum holder of the invention comprise an insertfitted into the body of the septum holder. The insert has either one ortwo bores that form the seats of needle valves.

In embodiments of the septum holder of the invention the septum isattached to the outside of the bottom of the body of the septum housing.

In embodiments of the septum holder of the invention comprising two armsthat are arranged in pairs, one arm located alongside the other arm onthe same side of the septum holder.

In embodiments of the septum holder of the invention the comprising fourarms wherein the arms are arranged in two pairs located on opposingsides of the septum holder.

In a second aspect the invention is a connector component comprising aseptum holder according to the first aspect of the invention, at leastone hollow needle, and an outer housing. The outer housing has the shapeof a right prism with a generally square cross-section, an open distal(bottom) end, and a proximal (upper) part adapted to connect to a firstcomponent of a fluid transfer system. The outer housing comprisessockets located at the distal end of its inner walls configured to holdthe rounded outwardly facing rear side of the distal enlarged element atthe bottom of each arm and the inner walls comprise guiding channels toguide the upward or downward movement inside the outer housing of thearms of the septum holder and an adapter component that is attached tothe septum holder during a connection or disconnection process betweenthe connector component and the adapter component.

In embodiments of the connector component of the invention the proximalpart of the outer housing is manufactured to have one of the followingstructures: a bore having a straight or tapered interior wall into whicha matching cylindrical or conical projection on the first component ofthe fluid transfer device can be press fitted, glued, or laser orultrasound welded; a standard male or female Luer type connector; and aLuer connectors that allows uni-directional or bi-directional swivelingof the first component of the fluid transfer device around the verticalsymmetry axis of the outer body of the connector.

In embodiments of the connector component of the invention, when theconnector component is not connected to any other component of a fluidtransfer system, the rounded rear side of distal enlarged elements ofthe arms are engaged in the sockets at the distal open end of outerhousing, the tips of the needles are isolated from the outside at thebottom by the septum and the walls of the bores in the insert in theseptum holder press radially on the shafts of the needles therebypreventing fluids from entering or exiting the interior of the needles.

In embodiments of the connector component of the invention each arm andenlarged element has its own set of independent guiding channels and canoperate independently from other arms and guiding channels, therebyeliminating deformation of the outer housing or the guiding channels byforces applied by the enlarged elements.

In a third aspect the invention is a swivel-connector comprising amechanical arrangement structured to allow uni and bi-directionalswiveling of a component of a fluid transfer apparatus attached to theswivel-connector. The mechanical arrangement is comprised of:

-   -   at least one tooth near the top of the inside wall of the        proximal end of a housing of the swivel-connector; a support        structure, which comprises a seat for an O-ring and a recess to        accommodate the lower end of a Luer element; and at least one        tooth created on the top of a horizontal flange near the bottom        of the support structure; and    -   a female Luer element with external threads to which a male Luer        element can be connected; the bottom of the female Luer element        comprising an upper flange and a lower flange with an annular        space between them and at least one tooth on the lower surface        of the lower flange.

The teeth near the top of the inside wall of a housing of theswivel-connector are configured to hold the female Leur element insidethe top of the swivel-connector. The teeth on the support structure ofthe housing of the swivel-connector have a triangular shape with anupper surface that slopes upwards in a counterclockwise direction andends at a vertical back surface and the teeth on the bottom of the lowerflange of the female Luer element have an upper surface that slopesupwards in a clockwise direction and ends at a vertical back surface.The teeth are located and oriented on their respective flanges such thatif the Luer element is turned relative to the swivel-connector housingin the counterclockwise direction, then the sloping surfaces of theteeth on both flanges will slide over each other allowing the rotationto be carried out in this direction and if the Luer element is turnedrelative to the swivel-connector housing in the clockwise direction,then the vertical surfaces on the teeth on both flanges will butt upagainst each other preventing relative motion between the female Luerelement and swivel-connector housing in this direction.

Embodiments of the swivel-connector of the invention comprise a spacebetween the bottom of the teeth near the top of the inside wall of theproximal end of a housing of the swivel-connector and the top of theupper flange of the female Luer element. This allows the Luer element tobe lifted the height of this space, whereupon the teeth on the on thesupport structure of the housing are vertically separated from the teeththe teeth on the bottom of the lower flange of the female Luer elementso that they can't interact with each other. This allows the female Luerelement to be rotated clockwise relative to the swivel-connectorhousing.

In a fourth aspect the invention is a factory assembledsyringe-connector unit, which comprises:

-   -   a syringe comprising a throat at the bottom of the syringe that        comprises an upper and a lower flange with an annular space        between them; and    -   a connector having a housing comprising at least one tooth        projecting inwards from near the top of the inner wall of the        proximal of the housing.

The distal end of the syringe and the proximal end of the connector aremanufactured from plastic that will flex when they are pushed togetherwith sufficient force, thereby allowing the lower flange to pass the atleast one tooth until the at least one tooth is located in the annularspace holding the syringe and the connector together. In thisconfiguration the syringe and connector can be swiveled relative to eachother in either clockwise or counterclockwise directions around theircommon longitudinal symmetry axis.

In a fifth aspect the invention is an adapter component for connectionbetween a connector component according to the second aspect of theinvention that comprises a septum holder according to the first aspectof the invention and a second component of a fluid transfer device. Theadapter component comprises an elongated extension having an externalsurface comprising features structured to couple with the septum holder.

In embodiments of the adapter component of the invention in which theseptum holder comprises two arms the features structured to couple withthe septum holder comprise for each of the two arms: a vertical grooveand a cut-out portion adapted to allow room for the arm and enlargedelement at the distal end of the arm to move during theconnection/disconnection process and a step-like structure located nearthe top of the elongated extension.

The step-like structure comprises: a first planar vertical surface on aside of the step-like structure facing away from the vertical grooveconfigured to slide along a guiding channel in the connector component;a second planar vertical surface on a side of the step-like structurefacing towards the vertical groove configured to slide along the tip ofthe pointed inwardly facing front side of the enlarged element at thedistal end of the arm; and a planar horizontal bottom surface configuredto engage the top surface of the pointed inwardly facing front side ofthe enlarged element at the distal end of the arm.

In embodiments of the adapter component of the invention in which theseptum holder comprises four arms the features structured to couple withthe septum holder comprise for each pair consisting of two arms ahouse-shaped structure located near the top of the elongated extension.

The house-shaped structure comprising two planar vertical surfacesconfigured to slide along the tips of the pointed inwardly facing frontside of the enlarged element at the distal ends of the two arms in thepair and a planar horizontal bottom surface configured to engage the topsurfaces of the pointed inwardly facing front sides of the enlargedelements at the distal ends of the two arms in the pair.

Embodiments of the adapter component of the invention are configured toconnect to one of: a vial, an IV bag, and an IV line.

In a sixth aspect the invention is a syringe comprising a sealingelement at its proximal end. The sealing element comprises a disk shapedannular sealing assembly having a hole in its center through whichpiston rod passes and an O-ring that seals around the piston rod. Thesyringe is characterized in that the sealing element is located insideits barrel.

In embodiments of the syringe of the invention the sealing assembly isheld in place and sealed to the inside of the syringe barrel by at leastone of: press fitting into the barrel, laser or ultrasound welding, heatwelding, and gluing.

All the above and other characteristics and advantages of the inventionwill be further understood through the following illustrative andnon-limitative description of embodiments thereof, with reference to theappended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross-sectional view of a prior art apparatus fortransferring hazardous drugs;

FIG. 2a to FIG. 2d are cross-sectional views that schematically show the4 steps connection sequence between the connector section and the vialadapter of the apparatus of FIG. 1;

FIG. 3a and FIG. 3b are cross-sectional views that schematically showthe concept of using the apparatus of FIG. 1 for transferring hazardousdrugs;

FIG. 4 shows an embodiment of the apparatus of FIG. 1 in which a filteris introduced into the air channel by placing it in the vial adapter;

FIG. 5a and FIG. 6a are schematic cross-sectional views of a prior artapparatus for transferring hazardous drugs identical to that shown inFIG. 4 disconnected from and connected to a vial adapter respectively,with the exception that the prior art double membrane seal actuator isreplaced with an actuator comprising a single membrane and an embodimentof a needle valve;

FIG. 5b and FIG. 6b are enlarged views of the actuator in the apparatusshown in FIG. 5a and FIG. 6a respectively;

FIG. 7a , FIG. 7b , and FIG. 7c are respectively front, cross-sectional,and exploded views of a first embodiment of a prior art septum holder;

FIG. 7d schematically shows the holder of FIG. 7a in a connector sectionof a closed system drug transfer apparatus;

FIG. 8a schematically shows a fluid transfer apparatus in which isincorporated the improved components of the present invention;

FIG. 8b symbolically shows all components of the fluid transferapparatus of FIG. 8a connected together;

FIG. 9a and FIG. 9b schematically show embodiments of a septum holder ofthe present invention;

FIG. 10a and FIG. 10b schematically show the difference between theattachment of the arms to the septum holder of the prior art and theseptum holder of the present invention;

FIG. 11a symbolically shows an adapter component for connection to aseptum holder having two arms according to the present invention;

FIG. 11b schematically shows the adapter component of FIG. 11a connectedto a septum holder;

FIG. 12a symbolically shows an adapter for connection to a septum holderhaving four arms according to the present invention;

FIG. 12b schematically shows the adapter of FIG. 12a connected to aseptum holder;

FIG. 13 shows an adapter for connecting a septum holder of a connectorcomponent according to the present invention to a spike port of an IVbag;

FIG. 14 schematically shows the exterior of a connector componentaccording to the present invention;

FIG. 15a to FIG. 15d symbolically show different stages in theconnection of a connector component to an adapter component according tothe invention;

FIG. 16a to FIG. 19 schematically show an embodiment of the proximal endof a connector that comprises a mechanical arrangement that allowsbi-directional swiveling of a component of a fluid transfer apparatusattached to the adapter;

FIG. 20a and FIG. 20b schematically show an embodiment of the proximalend of a connector that allows bi-directional swiveling of a syringethat is factory attached to it;

FIG. 21a schematically shows the proximal end of a prior art syringe;and

FIG. 21b to FIG. 21d schematically show the proximal end of anembodiment of a syringe according to the invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention is improved versions of some of the components ofthe fluid transfer apparatuses described in the background section ofthis application. FIG. 8a schematically shows fluid transfer apparatus100 in which are incorporated the improvements of the present invention.

Apparatus 100 comprises a first component—in this case syringe 102, aconnector component 104, an adapter component 106 to allow connection ofconnector component 104 to a second component—in this case vial 108.

The changes that have been made to apparatus 100 relative to the priorart and which will be described in detail below are the following:

-   -   the elements that seal the proximal end of the syringe 102 have        been redesigned resulting in an improved syringe;    -   the arms on the septum holder in the connector component 104        have been redesigned and the way in which they move in order to        carry out their function has been changed;    -   the exterior and interior of the outer housing of the connector        component 104 have been redesigned in view of the changes in the        arms on the septum housing;    -   the end of connector component 104 that connects to the first        drug container comprises a swivel function in some embodiments;        and    -   the proximal end of adapter component 106 has been changed to        allow it to be connected to connector component 104.

FIG. 8b symbolically shows the first and second components 102,108 offluid transfer apparatus 100 connected together by means of connectorcomponent 104 and adapter component 106.

FIG. 9a and FIG. 9b schematically show embodiments of septum holder 110of the present invention. The septum holders shown in these figures areidentical with the exception of the number of resilient arms 118—twoarms in FIG. 9a and four arms in FIG. 9 b.

Septum holder 110 is comprised of a cylindrically shaped annular body112. Two (or four) parallel equal length, downward extending, resilient,elongated arms 118 are attached to the sides of body 112. The armsterminate with distal enlarged elements 120. The distal enlargedelements are shaped roughly like a human foot with a rounded outwardlyfacing rear side and a pointed inwardly facing front side. The bottomsection of body 112 is comprised of a cylindrical section that projectsdownward parallel to arms 118. A cavity is created in the bottom part ofbody 112 into which is fitted an insert comprising one or two bores thatform the seats of needle valves. Ribs 114 or equivalent structure may bepresent in the interior of body 112 to provide mechanical strength andsupport to the insert.

Septum 116 is made of a single piece of cylindrically shaped resilientmaterial. The upper part of septum 116 has a hollow interior forming acylindrical recess having an inner diameter no larger than that of theouter diameter of the cylindrical section at the bottom of body 112.After the insert is fitted into the cavity in body 112, septum 118 isfitted over the cylindrical bottom section of body 112 (much as aknitted cap is pulled over a head) until the solid part of septum 118butts against the bottom of the bores in the insert; thereby isolatingthe bottoms of the interior of the bores from the external environment.Septum 118 is fixedly held facing downward on the body 112 of septumholder 110 by any means known in the art, such as described hereinabove.

FIG. 10a and FIG. 10b schematically show the difference between theattachment of the arms to the septum holder of the prior art and theseptum holder of the present invention. In the prior art a pair of armsis located facing each other on opposite sides of the septum holder. Theenlarged elements at the distal end of the arms move back and forthalong an extension of a diameter of the circular cross-section of thebody of the septum holder in the direction shown by the double headedarrows in FIG. 10a . In the septum holder of the invention a pair ofarms is located one alongside the other on the same side of the septumholder. The enlarged elements at the distal end of the arms move backand forth along extensions of parallel chords of the circularcross-section of the body of the septum holder in the directions shownby the double headed arrows in FIG. 10 b.

With the exception of the location at which the arms 118 are attached tothe sides of body 112, septum holder 110 is essentially identical to theprior art septum holder 58 described herein above in relation to FIG. 7ato FIG. 7c For this reason most of the structural elements of septumholder 110 are not illustrated herein and the reader is directed to FIG.7a , FIG. 7b , and FIG. 7c to see the corresponding structure in theprior art. It is noted that other prior art septum housings, for examplethe other embodiments described in the above referenced IL 23788, can beadapted mutatis mutandis, by locating the arms as described withreference to FIGS. 9a and 9b . It is also noted that septum housingsaccording to this invention can be manufactured having only one arm ormore than four arms. A very stable configuration can be obtained by theuse of three arms, although this would be a more complex embodiment tomanufacture.

FIG. 11a symbolically shows an adapter component 106 for connection to aseptum holder 110 having two arms according to the present invention.The distal (lower portion) of adapter component 106 is adapted toconnect to the second component of the fluid transfer apparatus and isnot relevant to the present invention. As in the prior art the interiorof the hollow elongated extension 122 of adapter component 106 containsa channel or channels to allow fluid communication between the interiorof the second component of the fluid transfer system and the needles inthe connector component 104, when connector component 104 and adaptercomponent 106 are connected. A septum 124 at the top of the elongatedextension seals the interior channels when adapter component 124 is notconnected to another element of a fluid transfer apparatus.

The exterior of elongated extension 122 is significantly different fromthat of prior art adapter elements (see for example FIG. 5b ). On theexterior surface are created—for each of the two arms, a vertical groove130, a cut-out portion 128, and a step-like structure 126 a. Thefunctional parts of section 126 a are planar vertical surface 126 b,planar vertical surface 126 c, and planar horizontal bottom surface 126d. The functions of these parts of 126 a will be described in moredetail herein below.

FIG. 11b schematically shows the elongated extension 122 of the adaptercomponent of FIG. 11a connected to septum holder 110. Elongatedextension 122 comprises groove 130 and cut-out portion 128 in which theenlarged element 120 at the distal end of arm 118 can move. If thediameter of the elongated extension 122 is small enough, then groove 130is not necessary. When the connection is complete, the flat uppersurface of the pointed front side of enlarged element 120 is caughtunder the flat lower surface 126 d of 126 b locking the septum holder110 and adapter 106 together.

FIG. 12a symbolically shows an adapter component 106 for connection to aseptum holder 110 having four arms according to the present invention.In this case there is created a projecting “house-shaped” structureinside a cut-out portion 134 on opposite sides of the outer surface ofthe proximal end of the elongated extension 122.

FIG. 12b schematically shows the adapter component of FIG. 12a connectedto a septum holder 110. The enlarged elements 120 at the distal ends ofarms 118 fit into the cut-out portion 134. The flat upper surface of the“toes” of enlarged elements 120 are caught under the flat lower surfaceof “house” 132 locking the septum holder 110 and adapter component 106together.

The changes to the exterior surface of the elongated extension of theadapter component dictated by the present invention can be made mutatismutandis to any of the adapters described in the prior art discussed inthe background section of this application, e.g. a vial adapter, a spikeadapter for connection to an IV bag, or a connector for connection to anIV line. FIG. 13 shows an adapter component 136 for connecting a to aspike port of an IV bag. Adapter component 136 has an elongatedextension 138 whose upper part has the same structure as shown in FIG.11a ; thereby allowing a septum holder such as shown in FIG. 9b to beattached to adapter component 136.

FIG. 14 schematically shows the exterior of connector component 104. Theinternal elements of connector 104, i.e. the septum holder and one ortwo needles, are surrounded by an outer housing 140. Outer housing 140has the shape of a right prism with a generally square cross-section andan open distal (bottom) end into which the proximal end of elongatedextension 122 of adapter component 106 can be inserted. The proximal(upper) part 142 of outer housing 140 can be constructed in many ways inorder to connect to a first component, e.g. a syringe or an IV line, ofa fluid transfer apparatus. Some of the ways in which proximal part 142can be constructed include: a bore having a straight or tapered interiorwall into which a matching cylindrical or conical projection on thecomponent of the fluid transfer device can be press fitted, glued, orlaser or ultrasound welded; standard male or female Luer typeconnectors; or newly designed Luer connectors that allow unidirectionalor bi-directional swiveling of the component of the fluid transferdevice around the vertical symmetry axis of the outer housing 140 of theconnector 104. The swivel type connectors will be described herein belowwith reference to FIGS. 16a -20 a.

FIG. 15a to FIG. 15d symbolically show different stages in theconnection of a connector component 104 of the invention to an adaptercomponent 106 of the invention. As in the prior art apparatuses of theapplicant, the connection is done by pushing the two components togetherand the “steps” of the process are similar. Also, as in the prior art,although the process is illustrated as a series of steps, in actualpractice it is carried out with one continuous smooth action. In thesefigures, the connector component has been rotated and part of outerhousing 140 has been removed to allow one arm 118 of septum holder 110to be seen. The one or two needles are not shown.

In FIG. 15a the proximal end of elongated extension 122 of adaptercomponent 106 has been inserted into the open distal end of outerhousing 140. Septum 116 of the connector component has not yet contactedseptum 124 of the adapter section and the arm 120 is in its normalrelaxed configuration with the rounded rear side of the enlarged element120 in a socket 146 that is created at the distal end of outer housing140 (see FIG. 15d ). The socket 146 is part of a guiding channel 113that is formed as a cavity in the interior surface or as a rib extendingfrom the interior surface of the plastic outer housing 140. Guidingchannel 113 guides and positions the rounded rear side of the enlargedelement 120 according the respective operation steps. Anothercorresponding guiding channel 111, which is made in a similar manner tochannel 113, guides the planar vertical surface 126 b, which glidesalong it.

In embodiments not illustrated herein, the sockets 146 and guidingchannels 111 and 113 are not formed on the interior wall of the outerhousing but are constructed in a frame-like structure that is supportedwithin the outer housing.

In FIG. 15b the two septa 116 and 124 are in the middle of the processof being pressed against each other, but the septum holder 110 has notstarted to move upwards inside outer housing 140 because the enlargedelement 120 remains immovably trapped inside of socket 146 with itsrounded rear side inside of socket 146 and the tip of its pointed frontside pressed against the vertical surface 126 c of element 126 a on theadapter component. Enlarged element 120 will remain trapped until thesepta are fully pressed together and only then it will be released formovement. Although the enlarged element 120 is pressing on the verticalsurface 126 c, the vertical surface 126 c which is part of element 126 ais prevented from moving sidewards because the planar vertical surface126 b is pressed against guiding channel 111. The vertical surface 126 bof the elongated extension 122 of adapter component 106 glides along thechannel 111 inside outer housing 140 and thereby dictates straight axialmotion of the components during the connection (and disconnection)process.

In FIG. 15c elongated extension 122 of adapter component 106 hasadvanced far enough into the interior of connector component 104 thatthe force used to press the two septa against each other forces septaholder 110 to start moving upward. The upper surface of the rounded rearside of enlarged element 120 slides along a sloped upper surface ofsocket 146 pushing the pointed front side of enlarged element 120against vertical surface 126 c of element 126 a on the adaptercomponent. As more force is applied the septa are pushed closer togetherand elongated extension 122 moves up relative to septum housing farenough so that the pointed front side of enlarged element 120 at the endof arm 118 passes the bottom of vertical surface 126 c.

In FIG. 15d the upper part of the pointed front side of enlarged element120 is hooked under the horizontal bottom surface 126 d of element 126 aon the elongated extension 122 of adapter component 106. The septumholder 110 and adapter component 106 continue to move up inside outerhousing 140 of connector section coupled together. Also seen in FIG. 15dare ribs 144 that are formed on the inside of the outer housing 140 toprovide mechanical strength.

As described with reference to the prior art fluid transfer apparatusesof the applicant, when the connector component 104 is not connected toany other component of a fluid transfer system, the rounded rear side ofdistal enlarged elements 120 of arms 118 are engaged in the sockets 146at the distal open end of outer housing 142. In this position the tipsof the needles are isolated from the outside at the bottom by septum 116and the walls of the bores in the insert pressing radially on the shaftsof the needles prevent fluids from entering or exiting the interior ofthe needles.

As described with reference to the prior art fluid transfer apparatusesof the applicant, when the connected septum holder 110 and adaptercomponent 106 move upwards the needle or needles in the connectorcomponent penetrate the two septa 116 and 124 establishing a pathway forfluid communication between components of the fluid transfer system thatare connected respectively to the proximal end of the connectorcomponent 104 and the distal end of adapter component 106.

The embodiment of the septum holder shown in FIG. 12a and FIG. 12b hasfour arms 120, which are actually two pairs of arms. This embodimentprovides a balance of forces in comparison to the embodiment of septumholder shown in FIG. 15a to FIG. 15d that comprises two arms only.During all steps of the connection operation each of the arms 120 in apair of arms in FIG. 12a and FIG. 12b presses on one side of the flatside surface of “house” 132 and tries to rotate it sideward. But sincethere are pairs of arms that work in opposing directions, the force thatis applied by one arm is neutralized by the force applied by the otherarm of the pair. The balanced pair of arms pressing one against theother eliminates the need for an equivalent component to gliding channel111 inside the outer housing 140 and the planar vertical surface 126 bas shown in FIG. 15a to FIG. 15 d.

One of the main reasons for developing the connector component 104described herein above is that in the prior art connector the arms andthe enlarged elements at their distal ends exert great force on theinner walls of the connector body during operation. As a result theconnector body, which is made of plastic, tends to deform by increasingits diameter. This may cause malfunction of the connector and breach ofsafety. One such typical malfunction is caused during disconnection: innormal operation during the disconnection procedure the connector andthe adapter are pulled apart; during pulling the adapter port is held bythe enlarged elements and only when they reach the area at the distalend of the connector body that has larger diameter (distal shoulderportion 19 in FIG. 1) are they able to expand and to release the adapterthat they have been holding all that time and the disconnection iscomplete. The problem occurs when the body is deformed due to the sideforces that the enlarged elements are applying on the inner walls of theconnector body. This deformation simulates the distal shoulder portionand the enlarged elements release the adapter too early, i.e. before theenlarged elements reach their destination in the distal shoulder portionand remain in a position that is a little too deep inside the connectorafter the adapter has been released. The disconnection seems at firstglance to be properly executed, but the reality is that since theenlarged elements were left too deep inside the connector body, whenanother connection is to be made the adapter will not slide between theenlarged elements and be held by them. In the contrary, the enlargedelements will be pushed by the adapter inside the body without creatingany connection and the needles will pierce the membranes and appearexposed to the environment and possibly leak while breaking the closedsystem.

An advantage of the new connector component 104 is that it doesn't relyon the stability of the connector body, since the arms and enlargedelements slide in the channels 111 and 113 formed by the rigid ribs thatare formed on the inside of the outer housing 140. Unlike the prior arteach arm and enlarged element has its own set of independent guidingchannels and can operate independently from other arms and guidingchannels and the forces that the enlarged elements apply don't deformthe outer housing or the guiding channels.

Another advantage of the new connector component is that the designallows for construction of a smaller connector and respective adaptersince, amongst other factors there is no need for the bulky distalshoulder portion of the prior art connector. Size is a crucial factorwith users since smaller products are easier to handle and will bepreferred in most applications.

FIG. 16a to FIG. 19 schematically show an embodiment of the proximal endof a connector that comprises a mechanical arrangement that allows uniand bi-directional swiveling of a component of a fluid transferapparatus attached to the connector. A special female Luer lock isprovided on the proximal end of the connector and any device such asinfusion tubing or a syringe with male Luer lock can be attached to itby a clockwise twisting motion. During the down pressing and clockwisetwisting motion of the male Luer lock, rotation of the female Luerelement of the connector is prevented as will be described herein below,thereby allowing the male Luer element to be rotated until theconnection is tight and no further twisting is necessary or possible.After the connection of the two Luer elements is completed, any attemptto twist them counterclockwise will result in endless swiveling withoutany disconnection occurring. The purpose of this arrangement is toprevent both, the unintended and the intended disconnection by theusers, such as by children in hospital while playing with an infusiontubing connection. Further, if the male Luer element is lifted a littleand rotated clockwise, this will also result in an endless swiveling.All parts that could be used for gripping to unlock the connection areinaccessible in this embodiment thereby providing a tamper proof Luerlock connection. This arrangement can be used with all embodiments ofboth the prior art connectors described in the background section ofthis application and the new connector components described herein.

FIG. 16a shows a connector component 104 of the present inventionadapted as a swivel connector. Proximal end 142 of outer housing 140 isa specially designed female Luer element 148 with external threads 150to which a male Luer element can be connected. FIG. 16b is across-sectional view of FIG. 16a . Seen in FIG. 16b are teeth 152 on theinner wall of proximal end 142 that hold Luer element 148 inside ofconnector component 104 and the channels 113 in which the arms 118 ofthe septum holder 110 move as the septum holder moves up and down insidethe connector element. Also seen are needle holder 168 that attaches theproximal end of needle 166 to the outer housing of the connectorcomponent. As can be seen and has been described herein above, when theconnector component is not connected to an adapter component, the tip ofneedle 166 is located inside of the insert in the body of the septumholder.

FIG. 17a shows a prior art connector 14 modified to have a proximal end142 according to the present invention. Area A, in which a section ofthe wall of proximal end is removed to show the internal elements, isenlarged in FIG. 19.

FIG. 17b is an exploded view showing the main parts of which the swivelconnector is assembled and how the bottom of the Luer element isdesigned. The swivel connector is comprised of a connector 14 (or 104)as described herein above, whose upper end has been modified, the femaleLuer element 148, and an O-ring, which prevents leakage of fluid betweenthe connector body and Luer element in the assembled swivel connector.The bottom of Luer element 148 comprises an upper flange 162 and a lowerflange 154 with an annular space 160 between them. Flange 154 has one ormore (typically four) teeth 156 on its lower surface that are part ofthe swivel mechanism.

Referring now to FIG. 18, which is a cross-sectional view of theproximal end 142 of the connector housing. The modifications made tothis part of the connector include the creation of one or more(typically four) teeth 152 near the top of the inside wall; a supportstructure 157, which comprises a seat for O-ring 164 and a recess toaccommodate the lower end of Luer element 148; and one or more(typically four) teeth 158 created on a horizontal flange near thebottom of support structure 157.

To assemble the swivel connector O-ring 164 is placed in its seat andthen Luer element 148 is pushed into the recess in the proximal end 140of the connector housing. All parts of the Luer element and theconnector housing are made of plastic that has enough resilience thatflange 154 on the bottom of the Luer element can be forced past teeth152, which move into space 160 holding the Luer element and housing ofthe connector together.

Referring now to FIG. 19 it can be seen that teeth 158 on the supportstructure 157 of the housing of the connector have a triangular shapewith an upper surface that slopes upwards in a counterclockwisedirection and ends at a vertical back surface and the teeth 156 on thebottom of flange 154 have an upper surface that slopes upwards in aclockwise direction and ends at a vertical back surface. If it isattempted to swivel Luer element 148 relative to the connector housingin the counterclockwise direction, then the sloping surfaces of teeth154 and 156 will slide over each other and Luer element 148 will riserelative to the connector housing until these surfaces pass each otherand then the Luer element will drop down and can continue to turn untilthe next pair of teeth encounter each other when the process repeats. Onthe other hand, if it is attempted to swivel Luer element 148 in theclockwise direction, then the vertical surfaces on teeth 154 and 156will butt up against each other preventing relative motion between theLuer element and connector housing in this direction.

The distance “h” between the bottom of teeth 152 and the top of flange154 allows the Luer element 148 to be lifted the height of “h” andswiveled clockwise; because, when the Luer element 148 is lifted toheight “h” the teeth 152 and 158 are separated from each other so theycan't interact with each other. When the Luer element is presseddownward and the distance “h” between the teeth 152 and 158 iseliminated, the teeth will engage each other and rotation clockwise willtighten even more the connection between the male and female Luerelements until it is not possible to twist anymore. This uni andbi-directional swivel feature prevents unintended disconnection oftubing or a syringe that has been Luer-locked to a connector, which is anot uncommon problem that occurs in the prior art. In order to separatethe two Luer-locked components they must be turned counterclockwise toeach other. With the swivel connector of the invention one componentwill freely spin with relation to the other and they will notdisconnect.

FIG. 20a and FIG. 20b schematically show an embodiment of the proximalend of a connector that allows bi-directional swiveling of a syringethat is attached to it. This syringe-connector unit is factory assembledand can comprise all embodiments of both the prior art connectorsdescribed in the background section of this application and the newconnector components described herein.

FIG. 20a is an exploded view showing the components of thesyringe-connector assembly. The throat at the bottom of the syringe ismanufactured so that it comprises two flanges 170 and 172 with anannular space 174 between them. The proximal end 142 of the housing 14(or 140) of the connector is manufactured with at least one toothprojecting inwards from near the top of the inner wall of the proximalend 142 of its housing.

FIG. 20b is a cross-sectional view showing the factory assembledsyringe-connector unit. After the O-ring 164 is placed in its seat, thedistal end of the syringe 12 and the proximal end 142 of the connectorare pushed together with sufficient force to allow the plastic parts toflex enough so that flange 170 passes teeth 152 and the teeth arelocated in annular space 174 holding syringe 12 and connector 14together. The O-ring prevents leakage of fluid between the connectorbody and syringe and the syringe is now able to swivel freely in bothclockwise and counterclockwise directions relative to the connector.

This swivel feature in the factory assembled syringe with connector isan improvement in comparison to prior art's stiff welded syringe withconnector. One advantage is that when a Luer-lock-adapter (a componentof a drug transfer system) is screwed on an infusion tubing and a priorart syringe with connector is connected to the adapter, it could happenthat the user will unscrew the adapter by rotating the attached syringe.This can happen because hospital personnel are used to screw or unscrew(Luer-lock or un-Luer) most of the equipment in the hospital. It canalso happen when the user, e.g. pharmacist or nurse, twists the syringein order to read the measurement marks. With the swivel design thesyringe will spin in relation to the connector, unscrewing will beprevented and the user, can easily and safely rotate the syringe to havean unobstructed view of the measurement markings on it.

FIG. 21a schematically shows the proximal end of a prior art syringe. Inthis syringe, in order to seal the distal end, a lid 180 is snapped overthe flange 176 that forms the finger grip at the top of the syringebarrel 18. An O-ring around piston shaft 24 and a gasket 182 isolate theinterior of the syringe from the outside.

This solution for sealing the top of the syringe, whether for closed oropen systems, means that the lid adds to the thickness of the flangethat exists on the syringe barrel. Such additional thickness hindersinsertion of the syringe into most of the existing electronic syringepumps that are used in hospitals for precise administration. Such pumpshave dedicated grooves for the syringe shape and are designed toaccommodate standard syringes.

The solution proposed by the present invention is to replace externallid 180 with a sealing element that is positioned inside the barrel ofan existing syringe. FIG. 21b to FIG. 21d schematically show theproximal end of an embodiment of a method of sealing the distal end ofthe syringe according to the invention. This sealing element comprises adisk shaped annular sealing assembly 184 having a hole in its centerthrough which piston rod 24 passes. This embodiment is comprised of anupper part 184 a and a lower part 184 b that are pressed together tohold an O-ring that seals around the piston rod. The sealing assembly ispushed into the top of the barrel of the syringe as shown in FIG. 21cand FIG. 21d . The sealing assembly 184 is then held in place and sealedto the inside of the syringe barrel by laser or ultrasound welding, heatwelding or gluing at the location indicated by the arrows in FIG. 21c .Alternatively the sealing assembly 184 can be press fitted into thebarrel and held in place by friction and the lateral forces exerted bythe sides of the plastic barrel and the sealing assembly against eachother. For added strength a notch 186 in the sealing assembly can snapinto a ridge 188 on the inside wall of the syringe barrel.

Embodiments of standard syringes that are not used in closed transfersystems can have a design that is not airtight, e.g. they can beprovided with ventilation holes that are either open directly to thesurroundings or protected by filters.

The sealing assembly 184 provides a solution to the prior art problembecause it is placed inside the barrel and doesn't disturb the externalshape of the syringe. Therefore it is compatible with syringe pumps andother medical equipment. Furthermore, it is easier to manufacture and inairtight applications it saves a whole component and its assembly,namely, the insertion of sealing ring between the lid and the barrel,which is difficult to accomplish correctly, is eliminated.

Although embodiments of the invention have been described by way ofillustration, it will be understood that the invention may be carriedout with many variations, modifications, and adaptations, withoutexceeding the scope of the claims.

1. A syringe configured for use in a syringe pump, the syringecomprising a flange at the proximal end of a barrel and a sealingelement at its proximal end, the sealing element comprised of a diskshaped annular sealing assembly having a hole in its center throughwhich a piston rod passes, the sealing assembly comprised of an upperpart and a lower part that are pressed together to hold an O-ring thatseals around the piston rod; the syringe characterized in that thesealing assembly is placed inside the barrel of the syringe; thereby notdisturbing the external shape of the syringe and allowing the syringe tofit into dedicated grooves on syringe pumps.
 2. The syringe of claim 1,wherein the sealing assembly is held in place and sealed to the insideof a barrel of the syringe by at least one of: press fitting, laserwelding, ultrasound welding, heat welding, and gluing.
 3. The syringe ofclaim 1, wherein the syringe can be used for either closed or opentransfer systems.
 4. A method of retrofitting a standard syringe to makeit suitable for use in a syringe pump, wherein the standard syringecomprises a lid snapped over the flange that forms a finger grip at thetop of the syringe barrel and an O-ring around a piston shaft and agasket that isolate the interior of the syringe from the outside;wherein, the method comprises: a) removing the lid the O-ring andgasket; b) inserting a sealing element into the proximal end of thebarrel of the syringe, wherein the sealing element is comprised of adisk shaped annular sealing assembly having a hole in its center throughwhich the piston shaft passes, the sealing assembly comprised of anupper part and a lower part that are pressed together to hold an O-ringthat seals around the piston rod; the retrofitted syringe characterizedin that the sealing assembly is placed inside the barrel of the syringe;thereby not disturbing the external shape of the syringe and allowingthe syringe to fit into dedicated grooves on syringe pumps.
 5. Themethod of claim 4, wherein the sealing assembly is held in place andsealed to the inside of a barrel of the syringe by at least one of:press fitting, laser welding, ultrasound welding, heat welding, andgluing.
 6. The method of claim 4, wherein the retrofitted syringe can beused for either closed or open transfer systems.